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eversense E3 User Manual

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Sensor
Smart Transmitter
LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 1
LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 1
Mobile App
User Guide
A guide for using the Eversense E3
Continuous Glucose Monitoring System
1/24/23 1:14 PM
1/24/23 1:14 PM

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Summary of Contents for eversense E3

  • Page 1 User Guide A guide for using the Eversense E3 Continuous Glucose Monitoring System Sensor Smart Transmitter Mobile App LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 1 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 1 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 2 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 2 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 2 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 3 Eversense E3 Trademark Eversense E3, Eversense E3 Continuous Glucose Monitoring, Eversense E3 CGM, Eversense E3 Sensor, Eversense E3 Smart Transmitter, Eversense App and the Eversense E3 logo are trademarks of Senseonics, Incorporated. Other brands and their products are trademarks or registered trademarks of their respective holders.

  • Page 4: Table Of Contents

    Get To Know the “My Glucose” Screen 58 3. Getting Started Trend Arrows Charge your Smart Transmitter Understanding Treatment Decisions Battery Indicator with CGM LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 2 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 2 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 5 Alert History on the Apple Watch Alert Descriptions and Actions Alerts and Notifications Displayed 10. Event Log on the Apple Watch LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 3 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 3 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 6 Apple Legal Notice Trend Arrows Google Legal Notice About Bluetooth® Sensor Bluetooth® Trademark Events FCC Information Sync Shortcuts Index 19. Device Performance LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 4 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 4 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 7: Glossary

    Eversense App to check the mobile device and is used to display CGM glucose data accuracy of the system. With the Eversense E3 System, sent from the smart transmitter. there are two phases: Initialization Phase during which...
  • Page 8 Remote Monitoring An optional feature that allows you “LO” Reading Indicates sensor glucose reading is to invite others to view your CGM data using Eversense < 40 mg/dL. NOW, a separate mobile app they download to a compatible mobile device.

  • Page 9: Introduction

    Congratulations on having Eversense E3 CGM technology to assist you in managing your diabetes. Your Eversense E3 CGM System is intended to continually measure glucose levels for up to 180 days after your sensor is inserted. Glucose information collected by the system is automatically sent to your mobile device.

  • Page 10: Eversense E3 Cgm System Components

    The sensor is inserted under the skin (upper arm) and measures glucose in interstitial fluid for up to 180 days. These glucose levels are then calculated by the smart transmitter and sent to the app. Sensors provided with the Eversense E3 CGM System include the sacrificial boronic acid (SBA) design Sensor modification.
  • Page 11 Eversense App The Eversense App is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data in a variety of ways. It also provides alerts based on the glucose settings you choose. The Eversense App screens layouts will vary based on your mobile device’s model and/or operating system.
  • Page 12 Bluetooth device. Be sure to follow the specific safety guidelines mandated by the airline. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 10 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 10 1/24/23 1:14 PM...
  • Page 13 • Stores glucose data in the app and on the smart transmitter. • Provides remote monitoring capability to others using the Eversense NOW Mobile App. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 11 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 11...

  • Page 14: System Requirements

    End User License Agreement and Privacy Policy Use of the Eversense App is subject to the terms and conditions of the most current Eversense End User License Agreement and Eversense Privacy Policy. These documents are updated from time to time and are posted at www.eversensediabetes.com.

  • Page 15: Indications For Use

    Indications for Use The Eversense E3 CGM System is indicated for continually measuring glucose levels in adults (18 years or older) with diabetes for up to 180 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.

  • Page 16: Contraindications

    Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results. What is Included in this Kit This Eversense E3 Smart Transmitter Kit contains the following: Eversense E3 Smart Transmitter Power Supply (USB cable and AC power adapter) Also included in this package is this User Guide, Quick Reference Guide, Next Steps sheet, and a wallet card (not shown).

  • Page 17: Benefits And Risks

    System, a fingerstick blood glucose check with a home blood glucose meter should be performed prior to making treatment decisions. Failure to use the Eversense E3 CGM System in accordance with the instructions for use may result in you missing a hypoglycemic or hyperglycemic glucose event, which may result in injury.

  • Page 18: Risks And Side Effects

    Any medical issue related to the procedure or use of the device should be reported to your health care provider. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 16 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 16 1/24/23 1:14 PM...

  • Page 19: Warnings

    Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change. You should not make a treatment decision based solely on the sensor glucose value.
  • Page 20 CGM readings to make treatment decisions unless you have followed the instructions for daily calibration. • The Eversense E3 CGM System will not provide readings during the 24 hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor.

  • Page 21: Precautions

    A warm sensor could mean there is an infection or a sensor malfunction. • DO NOT attempt to use the Eversense App while operating a motor vehicle. • You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
  • Page 22 • The Apple Watch is a secondary display of Eversense E3 CGM data and should not be used in place of the primary Eversense E3 CGM display. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 20...

  • Page 23: Getting Started

    3. Getting Started This section describes the initial start-up steps required before you can begin using your new Eversense E3 CGM System on a daily basis. You may perform these steps before your health care provider inserts the sensor. To get started you need: •...

  • Page 24: Charge Your Smart Transmitter

    USB cable into the LED Indicator USB port of the smart (lights green transmitter. or orange) Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 22 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 22 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 25: Battery Indicator

    10% charged Solid green when connected 100% charged Ready to use. to the USB cable Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 23 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 23 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 26: Step 1. Download And Install The App

    Make sure that you have a wireless internet connection, the date and time are correct on your mobile device, and that Bluetooth is turned ON before continuing. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 24 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 24 1/24/23 1:14 PM...

  • Page 27: Step 2. Set Up The App - Account Creation, Pairing And Settings

    Once the app is downloaded, connect the app and smart transmitter by pairing the smart transmitter with your mobile device. Launch the app by tapping the Eversense App After you accept the Agreement, you will be icon on your mobile device. The END USER prompted to create and register an account with LICENSE AGREEMENT will appear.
  • Page 28 Note: The password is case sensitive. • Tap Done to return to the Eversense LOGIN screen. Note: If you have not received the confirmation email with the link to complete your registration within a few minutes, check your spam folder.
  • Page 29 Then tap Allow to ensure • you receive alerts when the app is in use or in the background. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 27 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 27 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 30 3 seconds to turn it on. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 28 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 28 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 31 DO NOT change the unit of measurement unless you have discussed it with your health care provider. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 29 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 29 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 32 Tap through the introduction screens that provide information about when to make treatment decisions with the Eversense E3 CGM System. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 30 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 30 1/24/23 1:14 PM...

  • Page 33: Smart Transmitter Connection Icons

    User Guide to become familiar with the app and its features. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 31 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 31 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 34: Linking The Sensor

    You can link your sensor to the smart transmitter any time after the sensor is inserted and the smart transmitter is paired with the Eversense App. To link the sensor, your mobile device must be connected to the internet and your transmitter must be charged, turned on, and paired with your mobile device.
  • Page 35 When positioning the smart transmitter over the sensor, it should be slightly above the center of the Tegaderm patch. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 33 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 33 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 36 It may take up to 5 minutes for the New Sensor Detected notification to be displayed. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 34 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 34 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 37 If your smart transmitter has expired, it cannot be linked to a sensor. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 35 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 35 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 38 Warning : The Eversense E3 CGM System will not provide readings during the 24 hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor.
  • Page 39 • This may assist you in properly positioning the transmitter over the sensor. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 37 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 37 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 40: Daily Transmitter Wear

    For the first few days, you'll wear the smart transmitter over the Tegaderm™ bandage. Always start with a transmitter that has been charged for at least 15 minutes. Your smart transmitter communicates with both the sensor and the app to provide CGM information. Your Eversense E3 Smart Transmitter does the following: • Powers the sensor.

  • Page 41: Daily Use

    : If your smart transmitter is damaged or cracked, DO NOT use, as this could create an electrical safety hazard or malfunction, and could result in electrical shock. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 39 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 39 1/24/23 1:14 PM...

  • Page 42: Using The Smart Transmitter

    You must touch the button directly with your finger – it cannot detect a touch through clothing. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 40 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 40 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 43 Position transmitter over sensor Blinks orange communication interrupted or site. If prompted, link sensor. not yet linked Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 41 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 41 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 44: Smart Transmitter Care And Maintenance

    • Dispose of the smart transmitter and all other system components according to local regulations. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 42 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 42 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 45: Secure The Smart Transmitter Over Inserted Sensor

    If you have any concerns about allergic reaction to silicones, contact your health care provider prior to use. Discard the patch after 24 hours of use. Peel off the paper backing with the Eversense E3 Align the smart transmitter over the sticky side Smart Transmitter outline on it.
  • Page 46 Placement Guide – Show More Detail Screen in the Linking the Sensor section. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 44 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 44 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 47 The smart transmitter should be positioned so that the patch wings lay horizontally on the arm. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 45 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 45 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 48: Calibrating The System

    6. Calibrating the System This section describes the calibration procedure and schedule of your Eversense E3 CGM System. Warning: DO NOT use alternative test sites such as your forearm when entering BG values for calibration. To ensure best performance, routine calibration is required using fingerstick readings from a blood glucose meter.
  • Page 49 In the 2 Daily Calibrations Phase, the Eversense E3 CGM System requires calibration every 12 hours in order to provide accurate readings. In the 1 Daily Calibration Phase, the Eversense E3 CGM System requires calibration every 24 hours. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily calibration.

  • Page 50: Calibration Phases

    Glucose readings will start displaying in the app a few minutes after the 2nd calibration is successfully completed. IMPORTANT: If your smart transmitter is not turned on and paired with the Eversense App and sensor, the system is not able to prompt you to calibrate.
  • Page 51 After 40 hours without a calibration value entered, you will receive a Calibration Expired Alert and the system returns to Initialization Phase. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 49 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 49 1/24/23 1:14 PM...
  • Page 52 Daily Calibration phase the system is in. In this situation, if you do not calibrate within 16 hours, no glucose values will be displayed. After 24 hours with no calibration, the system returns to Initialization Phase. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 50 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 50 1/24/23 1:14 PM...

  • Page 53: How To Calibrate

    You can enter the calibration value by tapping Calibrate from the main menu or from the Calibrate Now Notification or Alert. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 51 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 51 1/24/23 1:14 PM...
  • Page 54 Tap Done. Note: You cannot enter a calibration value that is older than 10 minutes. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 52 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 52 1/24/23 1:14 PM 1/24/23 1:14 PM...
  • Page 55 If the smart transmitter is removed before the calibration is complete, you will be prompted to calibrate again. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 53 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 53 1/24/23 1:14 PM...
  • Page 56 Blood Glucose Displayed when a manual BG value is Event Entry entered via the Event Log. Eversense E3 CGM User Guide LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 54 LBL-5402-01-001 Rev 2_Eversense E3 User Guide_mgdL_R2.indd 54 1/24/23 1:14 PM 1/24/23 1:14 PM...

  • Page 57: Using The App

    The app also stores your glucose history with up to 90 days of stored data. Note: When you log out of the Eversense App, your smart transmitter will not send glucose data to the app until you log back in.

  • Page 58: Eversense Account Management

    If you cannot access your CGM data, you should monitor your glucose using a home blood glucose monitor. The Eversense Mobile App will periodically check to confirm your log in information has not been changed via your Eversense DMS account.

  • Page 59: Check Your Mobile Device Settings

    Check Your Mobile Device Settings You will need a mobile device (such as your smartphone) to use the Eversense E3 CGM System. It is very important that your mobile device is set up properly to ensure accurate display of your glucose data in the app. Follow the manufacturer’s instructions for your mobile device to set up the following:...
  • Page 60 Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change.

  • Page 61: Trend Arrows

    Note: • You can view a snapshot of Eversense information on your iOS or Android devices. For information on managing widgets, consult your mobile device user guide. • You can view the MY GLUCOSE screen in landscape orientation to access short cut buttons to view the last 7, 14, 30 or 90 days and you can email this view with a single tap.

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